A Prospective, Randomized, Double-Blind Study of Vaginal Microflora and Epithelium in Women Using a Tampon with an Apertured Film Cover Compared with Those in Women Using a Commercial Tampon with a Cover of Nonwoven Fleece

Abstract

Healthy women with normal menstrual cycles were randomly assigned to use either a test tampon during cycle 1 and a reference tampon during cycle 2 or a reference tampon during cycle 1 and a test tampon during cycle 2. Tampons were identical except for their cover materials: apertured film for the test tampon and nonwoven fleece for the reference tampon. Product use was doubly blinded. Qualitative and quantitative analyses of vaginal cultures were done pre-, mid-, and postmenstrually for a broad panel of microorganisms, colposcopy was performed, and diary reports were collected; 101 of 105 enrolled subjects completed the study. Midmenstrual findings for a variety of organisms differed from pre-and postmenstrual observations whether subjects were using test or reference tampons. No statistically significant differences were noted in prevalence or colony counts at premenstrual versus mid-and postmenstrual visits for most microorganisms. Prevalences of Gardnerella and anaerobic gram-negative rods were significantly different between tampons at the premenstrual visit, when unusually low values were observed for the test and reference tampons, respectively. None of the changes or differences in microflora were considered to be clinically significant. It is noteworthy, however, that declines in the prevalence and abundance of Lactobacillus during the menstrual periods were less pronounced during the use of both test and reference tampons than those reported from previous studies. Colposcopy showed no abnormal findings with either tampon and no changes in vaginal or cervical epithelial integrity. Thus, all evidence from both microbiological and colposcopic evaluations indicates that the apertured film cover of the test tampon is as safe as the nonwoven cover of the reference tampon.

Randomized, Double-Blind Crossover Study of Vaginal Microflora and Epithelium in Women Using a Tampon with a “Winged” Apertured Film Cover and a Commercial Tampon with a Nonwoven Fleece Cover

“…The study design, including subject inclusion/exclusion criteria and study procedures/assessments, duplicates that of a similar study published previously (1). In brief, this was a double-blind, randomized, two-way crossover study comparing the current commercially available reference tampon (o.b.…”

“…Details of statistical analyses and sample size calculations are also available in the previous publication by Chase et al (1). In brief, no single microorganism or other variable formed using a combination of single microorganisms was considered to be the primary clinical outcome.…”

“…At the pre-, mid-, and postmenstrual visits, the following microorganisms were identified and evaluated quantitatively by methods described previously (1): Lactobacillus species, Staphylococcus aureus, Escherichia coli, group B Streptococcus, Gardnerella vaginalis, anaerobic Gram-negative rods, Enterococcus species, Candida albicans, and Candida species.…”

“…Since their introduction in the 1930s, the acceptance of tampons has been supported by demonstrations of their safety in clinical studies involving microbiological analyses, gynecological examinations, and subjects' evaluations (1,6,13,14). Vaginal microflora studies conducted at various time points during the menstrual cycle have shown tampons to have no significant effect on the qualitative or quantitative changes in either the aerobic or anaerobic organisms that occur normally during menses (2, 7-11, 15, 16, 18).…”

“…Comfort from Johnson & Johnson; initially introduced in Germany and subsequently in other European countries as well as in the United States) after being shown in consumer studies to provide noticeable benefits with respect to ease and comfort of use (insertion and removal, in particular). A clinical study was conducted to demonstrate that this new film-covered tampon was as safe as its fleececovered predecessor and did not differ with respect to effects on either the vaginal epithelium or the vaginal microflora (1).…”